Editorials

Better reporting of randomised controlled trials: the CONSORT statement

Randomised controlled trials are the best way to compare the effectiveness of different interventions. Only randomised trials allow valid inferences of cause and effect. Only randomised trials have the potential directly to affect patient care--occasionally as single trials but more often as the body of evidence from several trials, whether or not combined formally by meta-analysis. It is thus entirely reasonable to require higher standards for papers reporting randomised trials than those describing other types of study.

Like all studies, randomised trials are open to bias if done badly.¹ It is thus essential that randomised trials are done well and reported adequately. Readers should not have to infer what was probably done, they should be told explicitly. Proper methodology should be used and be seen to have been used. Yet reviews of published trials have consistently . . . [Full text of this article]

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• Abrahamyan, L., Johnson, S. R., Beyene, J., Shah, P. S., Feldman, B. M. (2008). Quality of randomized clinical trials in juvenile idiopathic arthritis. Rheumatology (Oxford) 47: 640-645 [Abstract] [Full text]  
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• Fletcher, K., Mant, J., Holder, R., Fitzmaurice, D., Lip, G. Y., Hobbs, F. R. (2007). An analysis of factors that predict patient consent to take part in a randomized controlled trial. Fam Pract 24: 388-394 [Abstract] [Full text]  
• Gerber, A. J., Kocsis, J. H., Milrod, B., Roose, S. P. (2006). Assessing the Quality of Randomized Controlled Trials of Psychodynamic Psychotherapy. J Am Psychoanal Assoc 54: 1307-1312  
• Matthieu, M., Ivanoff, A. (2006). Treatment of Human-Caused Trauma: Attrition in the Adult Outcomes Research. J Interpers Violence 21: 1654-1664 [Abstract]  
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• Tiruvoipati, R., Balasubramanian, S. P., Atturu, G., Peek, G. J., Elbourne, D. (2006). Improving the quality of reporting randomized controlled trials in cardiothoracic surgery: The way forward.. J. Thorac. Cardiovasc. Surg. 132: 233-240 [Abstract] [Full text]  
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• Kober, T., Trelle, S., Engert, A. (2006). Reporting of randomized controlled trials in Hodgkin lymphoma in biomedical journals.. JNCI J Natl Cancer Inst 98: 620-625 [Abstract] [Full text]  
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• Tuech, J J, Pessaux, P, Moutel, G, Thoma, V, Schraub, S, Herve, C (2005). Methodological quality and reporting of ethical requirements in phase III cancer trials. J. Med. Ethics 31: 251-255 [Abstract] [Full text]  
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• Stolberg, H. O., Norman, G., Trop, I. (2004). Randomized Controlled Trials. Am. J. Roentgenol. 183: 1539-1544 [Full text]  
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• Leff, J., Everitt, B. (2001). Authors' reply. Br. J. Psychiatry 178 : 181b-182b [Full text]  
• Pickering, R M (2001). Describing the subjects in a study. Palliat Med 15: 69-75  
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• Newcombe, R. G. (2000). Reporting of Clinical Trials in the JO--the CONSORT Guidelines. J. Orthod. 27: 69-70 [Full text]  
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• Wade, A. (2000). Fear or favour? Statistics in pathology. J. Clin. Pathol. 53: 16-18 [Full text]  
• Newcombe, R. G. (1999). The Controversy Over How to Present Research Findings. J. Orthod. 26: 233-234 [Abstract] [Full text]  
• Roberts, C., Torgerson, D. J (1999). Understanding controlled trials: Baseline imbalance in randomised controlled trials. BMJ 319: 185-185 [Full text]  
• Sleep, J., Clark, E. (1999). Weighing up the evidence: The contribution of critical literature reviews to the development of practice. Journal of Research in Nursing 4: 306-313 [Abstract]  
• Education Group for Guidelines on Evaluation, (1999). Guidelines for evaluating papers on educational interventions. BMJ 318: 1265-1267 [Full text]  
• Hawkins, B. S. (1999). The CONSORT Statement: Will It Lead to Improved Reporting of Clinical Trials in Ophthalmology?. Arch Ophthalmol 117: 677-680 [Full text]  
• Bardhan, K D, Müller-Lissner, S, Bigard, M A, Porro, G B., Ponce, J, Hosie, J, Scott, M., Weir, D G, Gillon, K R W, Peacock, R A, Fulton, C. (1999). Symptomatic gastro-oesophageal reflux disease: double blind controlled study of intermittent treatment with omeprazole or ranitidine. BMJ 318: 502-507 [Abstract] [Full text]  
• Featherstone, K., Donovan, J. L (1998). Random allocation or allocation at random? Patients' perspectives of participation in a randomised controlled trial. BMJ 317: 1177-1180 [Abstract] [Full text]  
• Bath, F. J., Owen, V. E., Bath, P. M. W. (1998). Quality of Full and Final Publications Reporting Acute Stroke Trials : A Systematic Review. Stroke 29: 2203-2210 [Abstract] [Full text]  
• WARWICK, D., HARRISON, J., GLEW, D., MITCHELMORE, A., PETERS, T. J., DONOVAN, J. (1998). Comparison of the Use of a Foot Pump with the Use of Low-Molecular-Weight Heparin for the Prevention of Deep-Vein Thrombosis after Total Hip Replacement. A Prospective, Randomized Trial. JBJS 80: 1158-66 [Abstract] [Full text]